| CTRI Number |
CTRI/2025/12/098480 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Laser Treatment and Medicated Dressings to Reduce Pain During Repeat Root Canal Procedures in Adults. |
|
Scientific Title of Study
|
Effectiveness of LLLT Versus Intracanal Medicaments in Pain Management and Microbial Reduction During Endodontic Retreatment- Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saee Anawalikar |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics Clinic 21, Saveetha Dental College and Hospital
Chennai
TAMIL NADU
600077
India |
| Phone |
9922956700 |
| Fax |
|
| Email |
drsaeeanawalikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Solete |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Saveetha Dental College and Hospital
Chennai
TAMIL NADU
600077
India |
| Phone |
9922956700 |
| Fax |
|
| Email |
pradeeps@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Saee Anawalikar |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Clinic 21, Saveetha Dental College and Hospital Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9922956700 |
| Fax |
|
| Email |
drsaeeanawalikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, Chennai 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
|
|
Primary Sponsor
|
| Name |
Saee Anawalikar |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saee Anawalikar |
Saveetha Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Clinic 21, Saveetha Dental College and Hospital, Chennai
Chennai
TAMIL NADU |
09922956700
drsaeeanawalikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
failed root canal treatment |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 Low level laser |
Diode laser - wavelength for endodontic retreatment 810-890nm |
| Comparator Agent |
Group 2 Calcium hydroxide |
Intracanal medicament for endodontic retreatment
ph- 12.8 |
| Comparator Agent |
Group 3 Modified Triple Antibiotic paste |
Intracanal medicament for endodontic retreatment (metronidazole, ciprofloxacin, clindamycin) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient without any systemic diseases.
Patient having pain in root canal treated teeth and requiring retreatment |
|
| ExclusionCriteria |
| Details |
Patient without systemic conditions
teeth requiring extraction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain control |
preoperative, 6 hours, 24 hours, 48 hours and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Microbial Reduction |
Preoperative and before obturation |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to evaluate the efficacy of low level laser therapy vs intracanal medicaments in postoperative pain reduction and microbial reduction in patients undergoing retreatment. Patients requiring retreatment in previously failed symptomatic root canal retreatment will be included in the study. Patients with systemic diseases, teeth requiring extraction were excluded from the study. 45 Participants are to be divided into 3 groups, Group A- Low level laser therapy, Group B- calcium hydroxide Group C- Triple antibiotic paste and then postoperative pain to be assessed preoperatively, at 6 hours, 24 hours, 48 hours and after 7 days. Microbial reduction is also to be assessed preoperatively and postoperatively. The study aims to compare the efficacy of low level laser therapy versus intracanal medicaments in pain reduction and microbial reduction |